Intraocular Accommodating Lens and Methods of Use

ABSTRACT

Described herein are intraocular lenses and methods of implantation. In one aspect, the lens includes a shape changing optical element; a force translation element having a first end region coupled to the optical element and a second end region extending towards a ciliary structure, and an attachment portion coupled to the second end region of the force translation element and configured to contact the ciliary structure. The force translation element is configured to functionally transmit movements of the ciliary structure into a force exerted upon the optical element to effect an accommodating and a disaccommodating change of the optical element.

REFERENCE TO PRIORITY DOCUMENT

This application is a continuation of co-pending U.S. patent applicationSer. No. 13/366,165, entitled “Intraocular Accommodating Lens andMethods of Use,” filed Feb. 3, 2012, which claims the benefit ofpriority to U.S. Provisional Patent Application Ser. No. 61/439,767,entitled “Intraocular Accommodating Lens and Methods of Use,” filed Feb.4, 2011. Priority of the aforementioned filing dates is hereby claimedand the disclosures of the applications are hereby incorporated byreference in their entirety.

BACKGROUND

The present disclosure relates generally to the field of ophthalmics,more particularly to ophthalmic devices, including intraocular lenses(IOLs) such as accommodating intraocular lenses.

A healthy young human eye can focus an object in far or near distance,as required. The capability of the eye to change back and forth fromnear vision to far vision is called accommodation. Accommodation occurswhen the ciliary muscle contracts to thereby release the resting zonulartension on the equatorial region of the capsular bag. The release ofzonular tension allows the inherent elasticity of the lens capsule toalter to a more globular or spherical shape, with increased surfacecurvatures of both the anterior and posterior lenticular surfaces.

The human lens can be afflicted with one or more disorders that degradeits functioning in the vision system. A common lens disorder is acataract which is the opacification of the normally clear, naturalcrystalline lens matrix. The opacification can result from the agingprocess but can also be caused by heredity or diabetes. In a cataractprocedure, the patient's opaque crystalline lens is replaced with aclear lens implant or IOL.

In conventional extracapsular cataract surgery, the crystalline lensmatrix is removed leaving intact the thin walls of the anterior andposterior capsules together with zonular ligament connections to theciliary body and ciliary muscles. The crystalline lens core is removedby phacoemulsification through a curvilinear capsularhexis i.e., theremoval of an anterior portion of the capsular sac.

After a healing period of a few days to weeks, the capsular saceffectively shrink-wraps around the IOL due to the capsularhexis, thecollapse of the walls of the sac and subsequent fibrosis. Cataractsurgery as practiced today causes the irretrievable loss of most of theeye's natural structures that provide accommodation. The crystallinelens matrix is completely lost and the integrity of the capsular sac isreduced by the capsularhexis. The “shrink-wrap” of the capsular sacaround the IOL can damage the zonule complex, and thereafter the ciliarymuscles may atrophy. Thus, conventional IOUs, even those that profess tobe accommodative, may be unable to provide sufficient axial lens spatialdisplacement along the optical axis or lens shape change to provide anadequate amount of accommodation for near vision.

It is known to implant a combination of lenses to address refractionerrors in the existing lens in the case of phakic IOLs or improve therefractive results of standard IOL after cataract surgery in the case ofpseudophakic patients. These “piggyback” IOLs can be placed anterior tothe previously implanted IOL or natural lens to improve the refractiveresults of cataract surgery in the case of pseudophakes or to change therefractive status of the eye in the case of phakic eyes, usually tocorrect high myopia. Generally, these lenses are implanted in the sulcusand are non-accommodating.

SUMMARY

In one aspect, described herein is an intraocular lens including a shapechanging optical element; a force translation element having a first endregion coupled to the optical element and a second end region extendingtowards a ciliary structure, and an attachment portion coupled to thesecond end region of the force translation element and configured tocontact the ciliary structure. The force translation element isconfigured to functionally transmit movements of the ciliary structureinto a force exerted upon the optical element to effect an accommodatingand a disaccommodating change of the optical element.

The force translation element can be customized for fit duringimplantation. The mechanism for customizing the fit can include sliding,twisting, turning, cutting, rolling, expanding, bending, and applyingenergy to the force translation element. The force translation elementcan be coated with an expandable material. At least one of the opticalelement, the force translation element, and the attachment portion canbe coated with an agent having biological activity such as heparin, asteroid and rapamicin. The first end region of the force translationelement can be coupled to an equator of the optical element. A pluralityof force translation elements can be coupled near an equator of theoptical element.

The attachment portion can be configured to contact the ciliarystructure. The attachment portion can be configured to abut and notpenetrate the ciliary structure. The ciliary structure can be theciliary muscle, the ciliary body, a ciliary process, and a zonule. Theattachment portion can be formed of an elastic material. The attachmentportion can include one or more rods. The one or more rods can becurved. The attachment portion can include a three dimensional elementthat fills a space adjacent the ciliary structure. The attachmentportion can include a fillable element. The attachment portion caninclude a glue, hydrogel or fixation material. The attachment portioncan elicit a healing response in the ciliary structure to induce softtissue integration of the attachment portion.

The optical element can have a power in the range of about ±3 dioptersto about ±5 diopters. The accommodating change of the optical elementcan include a change from an ovoid shape to a more spherical shape. Theaccommodating change of the optical element can include a change inspatial configuration along the optical axis in an anterior direction.The force translation element can be formed of a material generallyharder than a material of the optical element. The second lens can bepositioned within the capsular bag of the eye. The optical element canbe positioned anterior to the second lens. The optical element can bepositioned within the capsular bag of the eye. The optical element canbe positioned posterior to the iris. The optical element can bepositioned anterior to the iris. The second lens can include animplanted intraocular lens.

The lens can further include a haptic coupled to and extending outwardfrom the optical element. The haptic can be positioned within a sulcus.The force translation element can be coupled to the haptic. The forcetranslation element can be coupled to the ciliary body to push on theoptical element.

The force translation element can be coupled to the ciliary body to pullon the optical element. The accommodating and disaccommodating changecan include a shape change effected over the entire surface of theoptical element. The accommodating and disaccommodating change caninclude a shape change effected over a portion of the optical element.The portion can preferentially bulge upon an accommodating change. Theshape change effected over a portion can be due to a difference inmodulus of the portion of the optical element compared to the modulus ofanother portion of the optical element. A center region of the opticalelement can include a lower modulus material than an outer region of theoptical element. The lower modulus material can give way causing a bulgeand a change in dioptric effect.

These general and specific aspects may be implemented using the devices,methods, and systems or any combination of the devices, methods andsystems disclosed herein. Other features and advantages should beapparent from the following description of various embodiments, whichillustrate, by way of example, the principles of the described subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a cross-sectional, schematic view of an eye showing anembodiment of an intraocular lens implanted anterior to anotherintraocular lens implanted in the capsular bag;

FIG. 2 depicts a cross-sectional, schematic view of the lens of FIG. 1during accommodation;

FIG. 3A depicts a schematic view of an embodiment of a lens;

FIG. 3B depicts a schematic view of another embodiment of a lens;

FIG. 3C depicts a cross-sectional view of the optical element of thelens of FIG. 3A;

FIG. 3D depicts a cross-sectional view of the optical element of thelens of FIG. 3B;

FIG. 4 depicts a schematic view of another embodiment of a lens havinghaptics and force translation elements;

FIGS. 5A-5B depict schematic top and side views, respectively of anotherembodiment of a lens having haptics and force translation elements;

FIGS. 6A-6B depict schematic views of force translation elements; and

FIGS. 7A-7B depict schematic views of additional embodiments of a lenshaving a hydrogel coating.

It should be appreciated that the drawings herein are exemplary only andare not meant to be to scale.

DETAILED DESCRIPTION

There is a need for improved methods and devices for the treatment ofpresbyopia in phakic and pseudophakic patients. The intraocular lensesdescribed herein can be switched back and forth repeatedly betweenaccommodation to disaccommodation, just as in a young accommodativenatural eye.

The term shape changing optical element refers to an optical elementthat is made of material that enables the optical element to alter itsshape, e.g., become one of more spherical in shape, thicker to focus ona closer object; or become more ovoid in shape, thinner to focus on amore distant and thus alter the optical element's respective optics(alter the dioptric power of the resulting optical element). The shapechange can be effected over the entire surface of the optical element,or just over a portion of the optical element, such as by having apreferential change or “bulge” in a portion of the optical element. Thiscan be achieved by varying the modulus of portions of the opticalelement. For example, the center region may be a lower modulus materialthan the outer region of the optical element in which case when theciliary body accommodates and the force will be translated to the centerof the optical element preferentially to cause a “bulge” that willprovide the desired dioptric effect.

Alternatively, the optical element may be a dual optic that is designedto translate relative to each other to increase or decrease the dioptricpower of the system.

The term accommodating shape refers to the shape of the optical elementwhen at least one of the contraction of the ciliary muscle of themammalian eye, the lower tension of the zonules of the mammalian eye anda decrease in the vitreous pressure in the eye occur to effect afocusing upon a closer object. An accommodating shape is generally morespherical than the disaccommodating shape.

The term disaccommodating shape refers to the shape of the opticalelement when at least one of the relaxation of the ciliary muscle of themammalian eye, the higher tension of the zonules of the mammalian eyeand an increase in the vitreous pressure in the eye occur to effect afocusing upon a more distant object. A disaccommodating shape isgenerally more ovoid than the accommodating shape.

The term diopter (D) refers to the reciprocal of the focal length of alens in meters. For example, a 10 D lens brings parallel rays of lightto a focus at ( 1/10) meter. After a patient's natural crystalline lenshas been surgically removed, surgeons usually follow a formula based ontheir own personal preference to calculate a desirable diopter power (D)for the selection of an IOL for the patient to correct the patient'spreoperational refractive error. For example, when a myopia patient with−10 D undergoes cataract surgery and IOL implantation, the patient cansee at a distance well enough even without glasses. Generally, this isbecause the surgeon has taken the patient's −10 D near-sightedness intoaccount when choosing an IOL for the patient.

The lenses described herein can mechanically or functionally interactwith eye tissues typically used by a natural lens during accommodationand disaccommodation such as the ciliary body, ciliary processes, andthe zonules, to effect accommodation and disaccommodation of theimplanted lens. The forces generated by these tissues are functionallytranslated to the optical element of the implanted lens causing a powerchange to allow a phakic or pseudophakic patient to more effectivelyaccommodate.

The intraocular lenses described herein can be implanted in the eye toreplace a diseased, natural lens. The intraocular lenses describedherein can also be implanted as a supplement of a natural lens (phakicpatient) or an intraocular lens previously implanted within a patient'scapsular bag (pseudophakic patient). The lenses described herein can beused in combination with intraocular lenses described in U.S. PatentPublication Nos. 2009/0234449 and 2009/0292355, which are eachincorporated by reference herein in their entirety. As such, the lensesdescribed herein can be used independently or as so-called “piggyback”lenses. Piggyback lenses can be used to correct residual refractiveerrors in phakic or pseudophakic eyes. The primary IOL used to replacethe natural lens is generally thicker and has a power that can be in therange of ±20 D. The thicker, larger power lenses generally have lessaccommodation. In contrast, the supplemental lens need not possess afull range of diopters (D). The supplemental lens can be relatively thincompared to the primary IOL and can undergo more accommodation. Shapechange and movement of the thinner lens is generally more easilyaccomplished relative to a thick primary lens. It should be appreciated,however, that the lenses described herein can be used independently andneed not be used in combination as piggyback lenses with the naturallens or an implanted IOL.

FIG. 1 depicts a cross-sectional view of an eye 5 including the cornea10, iris 15, sulcus 20, ciliary body 25, ciliary processes 27, zonules30 and the capsular bag 35 including an IOL 40 implanted in the capsularbag 35. A lens 100 is shown positioned within the sulcus 20 anterior tothe IOL 40. It should be appreciated that although the lens 100 is shownpositioned within the sulcus 20 and posterior to the iris 15 that it canalso be positioned anterior to the iris 15 within the anterior chamber45. The lens 100 can also be positioned within the capsular bag 35 justin front of the previously implanted IOL 40 or natural lens.

The lens 100 can include a central optical element 105 and at least twoforce translation elements 110 extending outward from the opticalelement 105 (see FIG. 2). The optical element 105 can be an adjustablelens such that the optical properties can be manipulated afterimplantation, as will be described in more detail below. The forcetranslation elements 110 can functionally couple with at least one ofthe ciliary structures such as the ciliary body 25, ciliary processes27, and/or the zonules 30 such that movements of these tissues duringaccommodation and disaccommodation are translated to the optical element105 via the force translation elements 110 to cause at least a change inshape or change in position of the optical element 105. The lens 100 canfurther include at least two haptics 115 coupled to and extendingoutward from the optical element 105. The haptics 115 can be positionedwithin the sulcus 20 to further aid in the anchoring of the lens in theeye.

FIG. 2 depicts a cross-sectional, schematic view of the lens 100 duringaccommodation. The ciliary body 25 is a generally circular structure.The ciliary muscle is a sphincter shaped like a doughnut. In naturalcircumstances, when the eye is viewing an object at a far distance, theciliary muscle within the ciliary body 25 relaxes and the insidediameter of the ciliary muscle gets larger. The ciliary processes 27pull on the zonules 30, which in turn pull on the lens capsule 35 aroundits equator. This causes a natural lens to flatten or to become lessconvex, which is called disaccommodation. During accommodation, themuscles of the ciliary body 25 contract and the inside diameter of theciliary muscle gets smaller. The ciliary processes 27 release thetension on the zonules 30 and the lens takes on its natural, more convexshape such that the eye can focus at near distance.

Without limiting this disclosure to any particular theory or mode ofoperation, the eye is believed to act on the implanted intraocularlenses described herein as follows. The force translation elements 110are implanted such that they are in contact with at least one of theciliary structures (i.e. zonules 30, ciliary processes 27 and/or ciliarybody 25). The contraction of the ciliary muscle and inward movement ofthe tissues towards the optical axis O applies a force against the forcetranslation elements 110 (see FIG. 2). The force translation elements110 transfer the force to the optical element 105, which can take on amore spherical shape suitable for near vision. This contraction of theciliary muscle and inward movement of the ciliary body 25 can alsoresult in a change in the spatial configuration of the lens 100 suchthat it axially displaces along the optical axis O forwardly in ananterior direction (distance D) relative to the natural lens or apreviously implanted IOL 40. Both the more spherical shape and theanterior movement away from IOL 40 can cause an increase in power neededfor accommodation and near vision focus.

As mentioned, the force translation elements 110 can be configured tocooperate with at least one of the ciliary body 25, ciliary processes27, or the zonules 30 to change the shape of the optical element 105. Itshould be appreciated that the vitreous pressure in the eye can also beinvolved in the accommodating shape of the optical element 105. Further,if the lens 100 is implanted anterior to the iris 15, for example withinthe anterior chamber 45, the structures of the anterior chamber anglecan also affect the accommodating shape change of the optical element105.

FIGS. 3A-3B depict an embodiment of an intraocular lens 100 having anoptical element 105 and two force translation elements 110 extendingoutward from near the equator of optical element 105. It should beappreciated that the force translation elements 110 can also extendoutward from other regions of the optical element 105. For example, theforce translation element 110 can be coupled nearer to one or more ofthe poles of the optical element 105. The force translation elements 110can be coupled to the optical element 105 or the force translationelements 110 can be coupled to and extend from haptics 115, if present.It should also be appreciated that the lens 100 can have more than twoforce translation elements 110 such as three, four, five or more forcetranslation elements 110. In one aspect, the force translation elements110 can extend from the optical element 105 on opposing sides of theoptical axis O.

When implanted in the eye, an end of the force translation elements 110can be positioned adjacent the ciliary body 25 on either side of theeye. The force translation elements 110 can be adapted to translateforce applied by the adjacent tissues to the optical element 105 tocause a shape change or a relative spatial change or both. The forcetranslation elements 110 can be generally formed of a harder materialthan that of the optical element 105. A change in hardness or durometercan be accomplished via a change in material. For example, a higherdurometer material can be used for the force translation elements 110than the material used for the optical element 105. For example, theforce translation elements 110 can be made from silicone and the opticalelement 105 can be made from a softer hydrogel. Alternatively, thematerials of the force translation elements 110 and the optical element105 can be the same, but the hardness different. Hardness can bedetermined or quantized using the Shore A or Shore D scale. The variousmaterials considered herein for forming the components of the lens 100are discussed in more detail below.

As mentioned, the optical element 105 can change to a more sphericalshape during accommodation upon narrowing of the inside diameter of theciliary body 25 by mechanically and functionally connecting with themovement of one or more of the ciliary tissues. As shown in FIG. 3A,contraction of the muscles of the ciliary body 25 can create a force inthe direction of arrows A, which is then applied to the forcetranslation elements 110. The force translation elements 110 translatethat force to the optical element 105 (arrows B). Depending on thedesign of the optical element 105, the optical element 105 can changeshape, for example, along arrows C shown in FIGS. 3A and 3B into a morespherical, accommodated shape to view a near object. If a far object isto be viewed, the optical element 105 can return to its resting,disaccommodating shape, which is more flat upon relaxation of theciliary body 25 and return to its posterior-most resting configurationdecreasing its effective power because the force translation elements115 are no longer being urged inward by the surrounding tissues.

The optical element 105 can be designed to include a variety of featuresthat cause an accommodative change in power. The optical element 105 caninclude internal cleavage planes to cause bulging in the center of theoptical element 105 when the ciliary body 25 and its associated tissuesare in the accommodative position increasing the power in the center ofthe optical element 105 (as shown in FIG. 3B). The optical element 105can also be fluid-filled such that movement of the ciliary body 25 andits associated tissues can cause the fluid to move and bulge near thecenter of the optical element 105 increasing its power. Theconfiguration of the optical element 105 can vary as is described inU.S. Patent Publication Nos. 2009/0234449 and 2009/0292355, which areeach incorporated by reference herein in their entirety.

As an example, FIG. 3C illustrates an optical element 105 having anouter lens portion 305 and a core lens portion 307. The outer lensportion 305 can be structured to include a center section 320 that canhave a reduced thickness or hardness. The center section 320 cansurround the optical axis O of the optical element 105 and can belocated on or near the anterior face 310 thereof. When the lens 100, andin particular the optical element 105, is compressed, for example by aninward force at peripheral regions 325 and 330 applied by the forcetranslation elements 110, the optical element 105 can be reshaped by anoutward bowing of the anterior face 310. This inward force by the forcetranslation elements 110 is due to the compressive force applied to theforce translation elements 110 by at least one of the ciliary body 25,ciliary processes 27, or zonules 30 depending on how the lens 100 isimplanted.

As shown in FIG. 3D, the outward bowing or reshaping can be especiallypronounced at region 335. This can be due to a reduced thickness of theouter lens portion 305 at center section 320. The reduced thickness canbe relatively more prone to give way from the internal pressure of thecore lens portion 307 upon inward force applied at the peripheralregions 325, 330. The core lens portion 307 can extend forward, as seenfor example in the central region 335 in FIG. 3D. The center section 320can also include a material of reduced hardness or increased elasticityto be more prone to give way from the internal pressure.

The extended central region 335 of optical element 105 can provide nearvision correction power. The remainder of the outer portion 305 outsidethe center section 320 can have a greater thickness that can be moreresistant to reshaping under such compression at the peripheral regions325, 330. As such, the annular region 340 of optical element 105extending radially outward of center section 335 can continue to providedistance vision correction power. The regions 335 and 340 of opticalelement 105, under compression, can provide both near and distancevision correction powers, respectively. In other words, the anteriorsurface 310 of optical element 105 can be a multifocal surface when theoptical element 105 is under compression. In contrast, when the opticalelement 105 is in the resting position as shown in FIG. 3C, the anteriorsurface 310 can be a monofocal surface.

FIG. 3D illustrates an alternative embodiment of the lens 100, which issubstantially the same as that shown in FIG. 3C, except for a differentconstruction of the outer portion 305. The center section 320 can bemade of a material that is relatively more susceptible to outward bowingthan is the peripheral region surrounding it. The center section 320 canbe injection molded in combination with the peripheral regionssurrounding it to provide a relatively seamless and uninterruptedanterior face 310, at least in the rest position of the lens 100. Whenthe peripheral regions 325 and 330 are squeezed towards the optical axisO, the core lens portion 307 can be placed in compression thus forcingthe center section 320 in the anterior direction as shown in theextended region 335. The material of the outer portion 305 can begenerally consistent, though the center section 320 can have a differentstiffness or elasticity that causes it to bow outward farther than thesurrounding region.

The extent to which central region 335 extends forwardly, and thereforethe magnitude of the near vision correction power obtainable by theoptical element 105, can depend on a number of factors, such as therelative thickness, hardness, stiffness, elasticity etc. of centersection 320, the overall structure of the outer portion 305 and/or theinner portion 307, the material of construction of the outer portionand/or the inner portion, the amount of force that the eye in which lens100 is placed can exert on the lens 100 and the like factors. The amountor degree of near power correction obtainable from lens 100 can becontrolled, or at least partially controlled, by varying one or more ofthese factors.

The embodiments of the optical element 105 described thus far, have aresting configuration when no forces being applied that are lower poweror more flat. During accommodation when the ciliary body pushes againstthe force translation elements 110, the optical element 105 can take ona more spherical, higher power configuration. It should be appreciated,however, that the optical element 105 can also mimic more closely anatural lens. In this embodiment, the optical element 105 is high poweror more spherical at a resting configuration when no forces are beingapplied to it. In this embodiment, the ciliary body relaxes duringdisaccommodation and applies tension to the force translation elements110 which translate a force on the optical element 105 such that theoptical element 105 flattens for low power and returns to the sphericalconfiguration during accommodation with the ciliary body contracts. Insuch a configuration, the force translation element 110 couldincorporate a more robust mechanism of attachment to the tissues.

The lenses described herein have the ability, in cooperation with theeye, to be reshaped to provide for both distance focus and near focus,and to be returned to its first configuration in which only distancefocus is provided. The amount of force required to effect a shape changein the optical element 105 is generally less than that of moving theoptical element 105 axially along the optical axis to achieve thedesired change in diopter. The change in diopter achieved by a shapechange is also generally larger than the change in diopter achieved byan axial displacement. The optical element 105 can have a power in therange of about ±1 D to about ±4 D or about ±5 D or about ±6 D. In anembodiment, the underlying power of the lens can be within the range ofabout ±5 D. In an embodiment, the underlying power of the lens can bewithin the range of about ±3 D. It should be appreciated that theoptical element 105 can also have a larger power in the range of about±20 D.

The force translation elements 110 contact the eye tissue by way of anattachment portion 120 (see FIG. 4). The mode of attachment provided bythe attachment portion 120 can vary. Generally, the attachment portion120 avoids piercing or causing trauma to the ciliary body 25. Theattachment portion 120 can interfere with the tissues such that movementof the ciliary body 25, ciliary processes 27 or zonules 30 can betransferred through the force translation elements 110 to the opticalelement 105 without causing trauma to the tissues themselves. Theattachment portion 120 can be formed of a material that is generallysofter or more elastic than the force translation elements 110. Thisprovides a more forgiving surface against which the tissues can abutsuch that piercing of the tissues and inadvertent trauma are avoided.This also allows for the attachment portion 120 to provide a better fitin that there is some room for error in the overall length and size ofthe lens 100 and its components. The elasticity of the material can alsofor a one-size-fits-all approach such that even if the measurement wasnot exact, the length of the translation elements 110 and attachmentportions 120 would be sufficient to effect shape change of the opticalelement 105 when needed while avoiding constant shape change or tissuedamage.

As an example, the attachment portion 120 can be a generally rigid,elongate rod or plurality of rods 125 (see FIG. 6A) positioned betweenand interfering with one or more zonules 30 or ciliary processes 27. Therods 125 can be straight, curved, or have a bend at a particular anglerelative to the longitudinal axis of the force translation element 110.As an example, the plurality of rods 125 can be curved such that theyform a cup that can interdigitate between the ciliary processes 27and/or zonules 30. The plurality of rods 125 can extend to the ciliarybody 25 with or without making contact with the ciliary body 25.

The attachment portion 120 can also have a three-dimensional shape thatfills a space surrounding the zonules 30 or ciliary processes 27 or thatfills the space above the ciliary body 25. As an example, the attachmentportion 120 can have a wedge shape such that the force translationelements 110 extends between the ciliary processes 27 and the attachmentportion 120 wedges up against the ciliary body 25. The attachmentportion 120 can also include a three-dimensional expandable element 123such as a bag, balloon or bulb coupled near an end of the forcetranslation element 110. FIG. 6B illustrates an attachment portion 120of an embodiment of a force translation element 110 having a pluralityof rods 125. One or more of the plurality of rods 125 can include anexpandable element 123 near a distal end region. A channel 127 canextend through an interior of the force translation element 110 into atleast a portion of each of the plurality of rods 125 such that thechannel 127 communicates with the expandable elements 123. A fluid(including a gas or liquid or gel) can be injected into a port or otherstructure positioned along the force translation element 110 and intothe channel 127 such that the expandable element 123 expands outwardinto one or more directions. The position of the port can vary, but isgenerally located so that it does not interfere with the optical part ofthe device. In some embodiments, the expandable elements 123 can expandthree-dimensionally such that they fill the space between the ciliaryprocesses 27 or around the ciliary body 25 or on top of the ciliaryprocesses 27 and covering the ciliary body 25. The expandable elements123 can be filled with a material to provide the desiredthree-dimensional shape, such as silicone oil, hydrogel, saline or othermaterial.

As shown in FIGS. 7A and 7B, the attachment portion 120 can include acoating 129 made of a material such as glue, hydrogel or other flowablematerial (see FIGS. 7A-7B). The coating 129 can fix the attachmentportion 120 in place. The coating 129 can also act to fill athree-dimensional space surrounding a particular tissue site to helpsecure the lens 100. The coating 129 can be injected through a port andinto a channel 127 extending through the interior of the forcetranslation element 110 into the attachment portion 120. One or moreopenings 131 positioned near a distal end region of the attachmentportion 120 can allow for the material to flow from the channel 127 toan external surface of the attachment portion 120 therein coating theexternal surface.

Soft tissue integration of the attachment portion 120 can be achieved bypositioning the attachment portion 120 in direct contact with one ormore of the ciliary tissues such that a minimal level of tissueirritation is achieved to set off a healing response. Upon tissueirritation, a minor inflammatory response ensues that is enough to causethe attachment portion 120 to become incorporated into the ciliaryprocesses 27 or ciliary body 25 without interfering with thephysiological role of the tissues. Tissue growth into and/or around theattachment portion 120 and integration of the device into the tissue canbe achieved without piercing or causing trauma to the tissue, forexample affecting its ability to produce aqueous humor.

It should also be appreciated that a combination of attachment portions120 with or without soft tissue integration are considered herein. Forexample, one or more expandable elements 123 can be coupled to an endregion of the attachment portion 120 that are also filled and coatedwith a material that provides fixing power such as glue or anotherflowable material. Further, the expanded shape of the expandable element123 can provide certain characteristics to the attachment portion 120.For example, the expandable element 123 when filled can form a wedgeshape such that it can be used as described above to wedge up againstthe ciliary body 25 or between the ciliary processes 27 when filled uponimplantation. The expandable elements 123 can also provide a degree ofcustomization to the attachment portion 120 such that the fit can bemodified during implantation. The expandable element 123 can bepositioned at a distal end region of the attachment portion 120 suchthat upon filling the expandable element 123 provides a customized sizethat provides the most beneficial fit to the device for a particularpatient.

The force translation elements 110 and/or the attachment portion 120 ofthe lens can be customized for length, angle and position relative tovarious structures of the eye. For example, the angle at which the forcetranslation elements 110 extend from the optical element 105 can play arole in the distance D away from the natural lens or previouslyimplanted IOL that the lens 100 is implanted, which in turn can impactthe focal power. Further, the length of the force translation elements110 can affect whether or not the force translation elements 110physically contact the ciliary body or neighboring tissues. If the forcetranslation elements 110 are too long and make contact with the ciliarybody in a resting state it is possible that the tissue structures can bedamaged or the optical element 105 can remain in a constant state ofaccommodation. Alternatively, if the force translation elements 110 aretoo short it is possible that not enough shape change would be achievedupon ciliary muscle contraction to effect proper accommodation. It isdesirable, therefore, to customize and adjust the length, angle,position or other characteristics of the force translation elements 110and/or the attachment portion 120 upon implantation. It should beappreciated that the customization can take place prior to implantationif the appropriate measurements are known in advance of the procedure.Alternatively, customization can take place on-the-fly duringimplantation or after implantation of the lens 100.

The length of each force translation element 110 can be adjusted by avariety of mechanisms including sliding, twisting, turning, cutting,rolling, expanding, etc. For example, the force translation element 110can be unrolled upon implantation in an outward direction from theoptical element 105 until the optimum length is achieved for properaccommodation to occur upon ciliary muscle contraction. Alternatively,the force translation element 110 can be twisted to reduce the overalllength it extends outward from the optical element 105. The forcetranslation element 110 can also be manually cut to an appropriatelength.

The force translation element 110 and/or the attachment mechanism 120can be formed of a shape-memory material or other stimuli-responsivematerial that has the capability of changing shape under an externalstimulus. For example, the stimulus can be a temperature change orexertion of an external force (compression or stretching). Theshape-memory material can be activated to extend to a pre-set length,shape or angle upon application of energy such as heat. The forcetranslation element 110 and/or the attachment mechanism 120 can beformed of an elastic or super-elastic material such as Nitinol.

The force translation element 110 and/or the attachment mechanism 120can be formed of or coated with a material that expands uponimplantation in the eye. The material can expand along a longitudinalaxis of the structure or the material can expand in three-dimensionallyso as to fill a void adjacent the component. For example, the expandedmaterial can fill a void adjacent the force translation element 110and/or attachment mechanism 120 such as the region between the ciliaryprocesses. Expandable materials can include, but is not limited to forexample, hydrogel, foam, lyophilized collagen, swelling acrylic, or anymaterial that gels, swells, or otherwise expands upon contact with bodyfluids. The expandable material can be positioned such that it causesthe force translation element 110 to move from a retracted state to anexpanded state such that it extends between or against an anatomicalstructure. The expandable material can also coat the attachmentmechanisms 120 and aid in the attachment mechanism 120 taking on apreferred shape. For example, the attachment mechanism 120 can be aplurality of rods coated by the expandable material such that uponimplantation the rods are forced outward away from one another.

As mentioned above, the force translation element 110 can be coupled toa region of the haptic 115. In an embodiment, the haptic 115 can bepositioned within the sulcus and the force translation element 110 canbe angled downward to reach the ciliary body. The force translationelement 110 can be twisted around the haptic 115 to achieve a desiredlength. Alternatively, the force translation element 110 can be coupledto the haptic 115 in such a way that it can be manually moved along thelength of the haptic 115 until the desired extension towards the ciliarybody is achieved.

The material of the components of the lenses described herein can vary.As mentioned above, the force translation elements 110 and haptics 115,if present, are generally formed of a material having a harder durometerthan the optical element 105 or the attachment mechanism 120 such thatthey can translate forces applied by the surrounding tissues to effectshape change and/or change in spatial configuration of the opticalelement 105. The force translation elements 110, attachment mechanism120, haptics 115 (if present) and optical element 105 can each be thesame material, but may have a hardness that differs to achieve thedesired functional characteristics when implanted.

Suitable materials for the preparation of the optical element 105disclosed herein vary and include materials that are known in the art.As an example, materials can include, but are not limited to, acrylicpolymers, silicone elastomers, hydrogels, composite materials, andcombinations thereof. Materials considered herein for forming variouscomponents are described in U.S. Patent Publication Nos. 2009/0234449and 2009/0292355, which are each incorporated by reference herein intheir entirety. The optical element 105 can also be formed from aphotosensitive silicone to facilitate post-implantation power adjustmentas taught in U.S. Pat. No. 6,450,642, entitled LENSES CAPABLE OFPOST-FABRICATION POWER MODIFICATION, the entire contents of which arehereby incorporated by reference herein.

Suitable materials for the production of the subject force translationelements 110 include but are not limited to foldable or compressiblematerials or hard materials, such as silicone polymers, hydrocarbon andfluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters,polyamides, polyimides, polyurethane, silicone polymers with hydrophilicmonomer units, fluorine-containing polysiloxane elastomers andcombinations thereof.

A high refractive index is a desirable feature in the production oflenses to impart high optical power with a minimum of optic thickness.By using a material with a high refractive index, visual acuitydeficiencies may be corrected using a thinner IOL.

The optical element 105 can also be formed from layers of differingmaterials. The layers may be arranged in a simple sandwich fashion, orconcentrically. In addition, the layers may include a series of polymerlayers, a mix of polymer and metallic layers, or a mix of polymer andmonomer layers. In particular, a Nitinol ribbon core with a surroundingsilicone jacket may be used for any portion of the lens 100 except forthe optics; an acrylic-over-silicone laminate may be employed for theoptics. A layered construction may be obtained by pressing/bonding twoor more layers together, or deposition or coating processes may beemployed.

Where desired, various coatings are suitable for one or more componentsof the lens 100. A heparin coating may be applied to appropriatelocations to prevent inflammatory cell attachment (ICA) and/or posteriorcapsule opacification (PCO); possible locations for such a coatinginclude the optical element 105. Coatings can also be applied to thelens 100 to improve biocompatibility; such coatings include “active”coatings like P-15 peptides or RGD peptides, and “passive” coatings suchas rapamicin, steroids, heparin, and other mucopolysaccharides,collagen, fibronectin and laminin. Other coatings, including hirudin,Teflon, Teflon-like coatings, PVDF, fluorinated polymers, and othercoatings which are inert may be employed to increase lubricity atlocations on the lens system, or Hema or silicone can be used to imparthydrophilic or hydrophobic properties to portions of the lens 100.

One or more of the lens components can also be coated with a therapeuticor other agent that ameliorates a symptom of a disease or disorderincluding, for example, steroids, small molecule drugs, proteins,nucleic acids, polysaccharides, and biologics or combination thereof.Therapeutic agent, therapeutic compound, therapeutic regimen, orchemotherapeutic include conventional drugs and drug therapies,including vaccines, which are known to those skilled in the art.Therapeutic agents include, but are not limited to, moieties thatinhibit cell growth or promote cell death, that can be activated toinhibit cell growth or promote cell death, or that activate anotheragent to inhibit cell growth or promote cell death. Optionally, thetherapeutic agent can exhibit or manifest additional properties, suchas, properties that permit its use as an imaging agent, as describedelsewhere herein. Exemplary therapeutic agents include, for example,cytokines, growth factors, proteins, peptides or peptidomimetics,bioactive agents, photosensitizing agents, radionuclides, toxins,anti-metabolites, signaling modulators, anti-cancer antibiotics,anti-cancer antibodies, angiogenesis inhibitors, radiation therapy,chemotherapeutic compounds or a combination thereof. The drug may be anyagent capable of providing a therapeutic benefit. In an embodiment, thedrug is a known drug, or drug combination, effective for treatingdiseases and disorders of the eye. In non-limiting, exemplaryembodiments, the drug is an antiinfective agent (e.g., an antibiotic orantifungal agent), an anesthetic agent, an anti-VEGF agent, ananti-inflammatory agent, a biological agent (such as RNA), anintraocular pressure reducing agent (i.e., a glaucoma drug), or acombination thereof. Non-limiting examples of drugs are provided below.

In an embodiment, the lens 100 and/or the mold surfaces are subjected toa surface passivation process to improve biocompatibility. This may bedone via conventional techniques such as chemical etching or plasmatreatment.

Once formed, the subject force translation elements 110 can bepermanently attached to optical element 105 by numerous methodsincluding but not limited to fastening within a pre-formed optic slotusing glue, staking, plasma treatment, friction, or like means orcombinations thereof.

Furthermore, appropriate surfaces (such as the outer edges/surfaces ofthe contacting elements, accommodating elements, etc.) of the lenscomponents can be textured or roughened to improve adhesion to theadjacent tissue surfaces. This can be accomplished by using conventionalprocedures such as plasma treatment, etching, dipping, vapor deposition,mold surface modification, etc.

In an embodiment, the selected material and lens configuration is ableto withstand secondary operations after molding/casting such aspolishing, cleaning and sterilization processes involving the use of anautoclave, or ethylene oxide or radiation. After the mold is opened, thelens can undergo deflashing, polishing and cleaning operations, whichtypically involve a chemical or mechanical process, or a combinationthereof. Some suitable mechanical processes can include tumbling,shaking and vibration; a tumbling process may involve the use of abarrel with varying grades of glass beads, fluids such as alcohol orwater and polishing compounds such as aluminum oxides. Process rates arematerial dependent; for example, a tumbling process for silicone canutilize a 6″ diameter barrel moving at 30-100 RPM. It is contemplatedthat several different steps of polishing and cleaning may be employedbefore the final surface quality is achieved.

A curing process may also be desirable in manufacturing the componentsof the lens 100. If the lens is produced from silicone entirely at roomtemperature, the curing time can be as long as several days. If the moldis maintained at about 50° C., the curing time can be reduced to about24 hours. If the mold is preheated to 100-200° C., the curing time canbe as short as about 3-15 minutes. The time-temperature combinationsvary for other materials.

It should be appreciated that the lenses described herein can beimplanted in a phakic or pseudophakic patient. In an exemplaryimplantation procedure, an IOL implantation is performed anterior to thenatural crystalline lens or anterior to a previously-implanted IOL.Although the implantation procedure can vary, one procedure can beperformed as follows. One or more clear corneal incisions can be formed.A first incision can be formed for IOL insertion and a second incisioncan be formed for manipulation and assistance of positioning the IOL. Aviscoelastic substance can be inserted into the eye, such as to at leastpartially fill the anterior chamber and/or an area between the iris andthe intra-capsular IOL. The IOL can be inserted into position in the eyeand the force-translation elements inserted into a desired position andconnected to the ciliary body. One or more IOL can be inserted into theciliary sulcus and the viscoelastic substance washed out of the eye. Acheck may then be performed to verify that the corneal incisions areappropriately sealed. Any of a variety of instruments may be used inconjunction with the procedure. Moreover, it should be appreciated thatthe aforementioned steps may be performed in a different order thandescribed above.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of an invention that is claimed orof what may be claimed, but rather as descriptions of features specificto particular embodiments. Certain features that are described in thisspecification in the context of separate embodiments can also beimplemented in combination in a single embodiment. Conversely, variousfeatures that are described in the context of a single embodiment canalso be implemented in multiple embodiments separately or in anysuitable sub-combination. Moreover, although features may be describedabove as acting in certain combinations and even initially claimed assuch, one or more features from a claimed combination can in some casesbe excised from the combination, and the claimed combination may bedirected to a sub-combination or a variation of a sub-combination.Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Only a few examples and implementations are disclosed.Variations, modifications and enhancements to the described examples andimplementations and other implementations may be made based on what isdisclosed.

What is claimed is:
 1. An intraocular lens, comprising: a shape changingoptical element comprising at least one of an anterior surface orposterior surface configured to bow along the optical axis of theoptical element upon application of a compressive force directedradially inward creating a shape change; a haptic coupled to the opticalelement, the haptic configured to anchor the optical element within theeye; and an accommodating element coupled to the optical elementcomprising a force translation element having a first end region coupledto the optical element and a second end region extending towards aciliary structure, wherein the force translation element is configuredto transmit movements of the ciliary structure during ciliary musclecontraction into the compressive force directed radially inward andexerted upon the optical element to effect the shape change of theoptical element.
 2. The intraocular lens of claim 1, wherein the forcetranslation element incorporates a mechanism for customizing a length ofthe force translation element.
 3. The intraocular lens of claim 2,wherein the mechanism can be used during or after implantation of theintraocular lens into the eye.
 4. The intraocular lens of claim 2,wherein the mechanism for customizing the fit is selected from the groupconsisting of sliding, twisting, turning, cutting, rolling, expanding,bending, and applying energy to the force translation element.
 5. Theintraocular lens of claim 1, wherein the haptic is separate from theaccommodating element.
 6. The intraocular lens of claim 5, wherein theforce translation element is coupled to a region of the haptic.
 7. Theintraocular lens of claim 6, wherein the force translation element iscoupled to allow movement of the force translation element along alength of the haptic.
 8. The intraocular lens of claim 7, wherein themovement of the force translation element achieves a desired extensionof the force translation element towards the ciliary body.
 9. Theintraocular lens of claim 6, wherein the force translation element iscoupled to allow twisting of the force translation element around thehaptic to shorten a length of the force translation element.
 10. Theintraocular lens of claim 1, wherein the force translation element isangled downward from the region of the haptic towards the ciliarystructure.
 11. The lens of claim 1, wherein at least one of the opticalelement and the force translation element is coated with an agent havingbiological activity.
 12. The lens of claim 11, wherein the agent isselected from the group consisting of an anti-coagulant, a steroidalanti-inflammatory, a non-steroidal anti-inflammatory, and ananti-metabolite.
 13. The lens of claim 1, wherein the first end regionof the force translation element is coupled to an equator of the opticalelement.
 14. The lens of claim 1, further comprising a plurality offorce translation elements coupled near an equator of the opticalelement.
 15. The lens of claim 1, wherein the ciliary structure isselected from the group consisting of the ciliary muscle, the ciliarybody, a ciliary process, and a zonule.
 16. The lens of claim 15, whereinthe accommodating element further comprises a contacting element coupledto the second end region of the force translation element, whereincontacting portion is configured to contact the ciliary structure uponcontraction movements of the ciliary muscle.
 17. The lens of claim 16,wherein the contacting portion does not penetrate the ciliary structureupon contact with the ciliary structure.
 18. The lens of claim 16,wherein the contacting portion is formed of an elastic material.
 19. Thelens of claim 16, wherein the contacting portion comprises one or morerods.
 20. The lens of claim 19, wherein the one or more rods are curvedto form a cup that interdigitates between one or more of the ciliarystructures.
 21. The lens of claim 16, wherein the contacting portioncomprises a three dimensional element that fills a space adjacent theciliary structure.
 22. The lens of claim 1, further comprising a secondlens positioned posteriorly to the optical element and within thecapsular bag of the eye.
 23. The lens of claim 22, wherein the secondlens is a natural lens of the eye or an intraocular lens.
 24. The lensof claim 1, wherein the optical element is positioned within thecapsular bag of the eye.
 25. The lens of claim 1, wherein the haptic isconfigured to be positioned within a sulcus.
 26. A method of implantingthe intraocular lens of claim 1, the method comprising: forming anincision in a cornea of an eye; inserting the intraocular lens into theeye through the incision; positioning the ocular element of theintraocular lens either inside or outside the capsular bag; andextending the accommodating element towards the ciliary structure suchthat during relaxation of the ciliary muscle the second end region ofthe force translation element is adjacent, but does not abut the one ormore ciliary structures and wherein during inward ciliary musclecontraction the second end region of the force translation element abutsthe one or more ciliary structures.
 27. The method of claim 26, whereinthe haptic is positioned into a sulcus.
 28. The method of claim 26,wherein the haptic is placed in the capsular bag.
 29. The method ofclaim 26, wherein the force translation element is coupled to an equatorof the optical element and transfers the force to the equator of theoptical element in a direction toward the optical axis.
 30. The methodof claim 29, wherein contraction of the ciliary muscle and inwardmovement of the ciliary body additionally changes spatial configurationof the optical element axially along the optical axis in an anteriordirection.